S2

Dosage form: solution
Ingredients: RACEPINEPHRINE HYDROCHLORIDE 11.25mg in 0.5mL
Labeler: Nephron Pharmaceuticals Corporation
NDC Code: 0487-5901

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

S2® - Racepinephrine Inhalation Solution, USP 2.25% Bronchodilator

Nephron Pharmaceuticals Corporation

OTC - ACTIVE INGREDIENT

Racepinephrine, USP 11.25 mg (as 13.5 mg of Racepinephrine HCl, USP)

OTC - PURPOSE

Bronchodilator

INDICATIONS AND USAGE

For temporary relief of mild symptoms of intermittent asthma:

Wheezing
Tightness of chest
Shortness of breath

WARNINGS

Asthma alert: Because asthma may be life threatening, see a doctor if you:

  • Are not better in 20 minutes
  • Get worse
  • Need more than 12 inhalations in 24 hours
  • Use more than 9 inhalations in 24 hours for 3 or more days a week
  • Have more than 2 asthma attacks in a week

These may be signs that your asthma is getting worse.

OTC - DO NOT USE
  • Unless a doctor said you have asthma
  • If you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
  • If product is brown in color or cloudy

OTC - ASK DOCTOR

Ask a doctor before use if you have:

  • Ever been hospitalized for asthma
  • Heart disease
  • High blood pressure
  • Diabetes
  • Thyroid disease
  • Seizures
  • Narrow angle glaucoma
  • A psychiatric or emotional condition
  • Trouble urinating due to an enlarged prostate gland

OTC - ASK DOCTOR/PHARMACIST

Ask a doctor or pharmacist before use if you are:

  • Taking prescription drugs for asthma, obesity, weight control, depression, or psychiatric or emotional conditions.
  • Taking any drug that contains phenylephrine, pseudoephedrine, ephedrine, or caffeine (such as for allergy, cough-cold, or pain).

OTC - STOP USE

Stop use and ask a doctor if:

  • Your asthma is getting worse (See Asthma alert)
  • You have difficulty sleeping
  • You have a rapid heartbeat
  • You have tremors, nervousness, or seizure

OTC - WHEN USING

When using this product:

Your blood pressure or heart rate may go up. This could increase your risk of heart attack or stroke, which may cause death.

Your risk of heart attack or stroke increases if you:

  • Have a history of high blood pressure or heart disease
  • Take this product more frequently or take more than the recommended dose.
Avoid foods or beverages that contain caffeine
Avoid dietary supplements containing ingredients reported or claimed to have a stimulant effect

OTC - PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.  In case of overdose, get medical help or contact a Poison Control Center right away.

DOSAGE AND ADMINISTRATION
Do not use more than directed

The ingredient is used in an aqueous solution at a concentration equivalent to 1 percent epinephrine

For use in a Hand-held Bulb Nebulizer:

Racepinephrine inhalation solution does not require dilution

For use in a Jet Nebulizer:

One 0.5 mL vial should be diluted to a volume of 3 to 5 mL with sterile 0.9% sodium chloride solution

Adults and children 4 years of age and over:
  • Hand-held Bulb Nebulizer: 1 to 3 inhalations not more often than every 3 hours
  • Jet Nebulizer: Administer for fifteen minutes every 3 to 4 hours
Do not use more than 12 inhalations in 24 hours. The use of this product by children should be supervised by an adult.
Children under 4 years of age: ask a doctor.

HOW SUPPLIED

S2® Racepinephrine Inhalation Solution, USP 2.25% is supplied in 0.5 ml sterile unit-of-use vials.

NDC 0487-5901-99 30 vials, each vial in an individual foil pouch.

NDC 0487-5901-10 10 vials, each vial in an individual foil pouch.

NDC 0487-5901-02 30 vials, each vial in an individual foil pouch, robot ready.

Storage and Handling

Protect from light.  Avoid excessive heat. Protect from freezing.
Store between 2° - 25° C (36 and 77°F).

INACTIVE INGREDIENT

Ascorbic acid, citric acid, edetate disodium, water for injection.

OTC - QUESTIONS

1-800-443-4313

Monday through Friday, 8:00 a.m. to 5:00 p.m. (Eastern Standard Time).

Manufactured By:

Nephron Pharmaceuticals Corporation

Orlando, FL  32811

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display Panel – Foil Pouch

NDC 0487-5901-99

NDC 0487-5901-10

S2® Racepinephrine Inhalation Solution, USP 2.25%

FOR ORAL INHALATION ONLY

Drug Facts

Active Ingredient: Racepinephrine, USP

Each 0.5mL contains 11.25mg (as 13.5mg of Racepinephrine HCl, USP).

Purpose: Bronchodilator

Uses: For temporary relief of mild symptoms of intermittent asthma:

Wheezing, Tightness of chest, Shortness of breath

See product carton for detailed information on Uses, Warnings, and Directions.

Other Information: Store at room temperature, between 2° - 25°C (36°F and 77°F). Protect from light.

Inactive Ingredients: Ascorbic acid, citric acid, edetate disodium, water for injection.

TAMPER EVIDENT FEATURE:

Do not use this product if the pouch is damaged or torn.

Do not use this product if it is brown in color or cloudy.

STERILE

One 0.5mL Unit-of-Use Vial

Principal Display Panel – Carton (30 individually wrapped vials)

NDC 0487-5901-99

S2® Racepinephrine Inhalation Solution, USP 2.25%

Bronchodilator

FOR ORAL INHALATION ONLY

TAMPER EVIDENT FEATURE:

Do not use this product if the pouch is damaged or torn.

SULFITE-FREE

PRESERVATIVE-FREE

Nephron Pharmaceuticals Corporation

Orlando, FL 32811

30x 0.5mL Sterile Unit-of-Use Vials, each in a foil pouch.

Principal Display Panel – Carton (10 individually wrapped vials)

NDC 0487-5901-10

S2® Racepinephrine Inhalation Solution, USP 2.25%

Bronchodilator

FOR ORAL INHALATION ONLY

TAMPER EVIDENT FEATURE:

Do not use this product if the pouch is damaged or torn.

SULFITE-FREE

PRESERVATIVE-FREE

Nephron Pharmaceuticals Corporation

Orlando, FL 32811

10x 0.5mL Sterile Unit-of-Use Vials, each in a foil pouch.

S2 
racepinephrine hydrochloride solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0487-5901
Route of AdministrationRESPIRATORY (INHALATION)DEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
RACEPINEPHRINE HYDROCHLORIDE (RACEPINEPHRINE) RACEPINEPHRINE11.25 mg  in 0.5 mL
Inactive Ingredients
Ingredient NameStrength
ASCORBIC ACID 
CITRIC ACID MONOHYDRATE 
EDETATE DISODIUM 
WATER 
Packaging
#Item CodePackage Description
1NDC:0487-5901-9930 POUCH (POUCH) in 1 CARTON
11 VIAL, SINGLE-USE (VIAL) in 1 POUCH
10.5 mL in 1 VIAL, SINGLE-USE
2NDC:0487-5901-0230 BAG (BAG) in 1 BOX
21 POUCH (POUCH) in 1 BAG
21 VIAL, SINGLE-USE (VIAL) in 1 POUCH
20.5 mL in 1 VIAL, SINGLE-USE
3NDC:0487-5901-1010 POUCH (POUCH) in 1 CARTON
31 VIAL, SINGLE-USE (VIAL) in 1 POUCH
30.5 mL in 1 VIAL, SINGLE-USE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34108/21/1991
Labeler - Nephron Pharmaceuticals Corporation (783905201)
Registrant - Nephron Pharmaceuticals Corporation (783905201)
Establishment
NameAddressID/FEIOperations
Nephron Pharmaceuticals Corporation783905201MANUFACTURE(0487-5901), ANALYSIS(0487-5901), PACK(0487-5901)

Revised: 05/2013
 
Nephron Pharmaceuticals Corporation

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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